Covance -
Indianapolis,
Indiana
32063BR
Clinical Research
At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities
We are currently seeking to add a home-based Project Director to our Early Clinical Development team. Those with Phase I, CNS, and/or Cardiovascular experience are encouraged to apply. This is a home based/remote position.
Essential Job Duties:
- Lead core project team and facilitate team's ability to lead extended/complete project team.
- Responsible for provision of client deliverables on-time, within budget and scope and with required quality for assigned projects or program.
- Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services.
- Resolve conflicts as needed.
- Ensure Six Sigma initiatives are implemented successfully on projects or programs.
- Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects or programs.
- Ensure that all staff allocated to assigned projects or programs adhere to professional standards and SOPs.
- Provide performance feedback on team members to respective functional areas.
- Monitor team performance and facilitate adjustments when necessary to ensure goal attainment.
- Present at external and/or internal meetings.
- Define and manage project or program resource needs and establish succession plans for key resources.
- Support business unit utilization targets.
- Implement and monitor progress against project plans and revise as necessary.
- Responsible for appropriate issue escalation to CAIR program and/or stakeholder(s).
- Serve as key client contact for assigned projects.
- Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business.
- Prepare and deliver presentations for new business in collaboration with business development.
- Prepare and actively participate as operational lead in internal Project Review meetings.
- Contribute to proposal strategy, development, costing, and bid defense for assigned business development opportunities.
- Partner with Financial Analyst to report revenue and milestone projections through study completion.
- Proactively identify out of scope activities, execute necessary change orders and support negotiations with client on project budget issues.
- Accountable for budget across assigned projects and/or programs.
- Develop strategies to control and minimize write-offs across projects and/or programs.
- Manage client expectations. Anticipate client needs and plan accordingly.
- Find creative and cost-effective ways to meet quality metrics agreed with client and key stakeholders.
- Use experience from past projects and lessons learned to adapt and implement quality improvements across projects currently being managed.
- Ensure project risks are discussed at project reviews. Monitor and control the risk plan and provide ongoing oversight to ensure mitigation plans are in place and working. Escalate risks newly identified by the project team to stakeholders.
- May be assigned line management responsibilities for the training, utilisation, development and performance review of assigned staff. In the absence of line management responsibilities, the Project Director will be expected to mentor project management staff.
- Develop and manage client project metrics.
- Perform other duties as assigned by management.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. Covance's ongoing success offers team members unsurpassed growth and career development opportunities.
There is no better time to join us!
Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
Education/Qualifications Required:
- University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
- Detailed knowledge of financial control procedures (e.g. costing systems,TAQ / EVA).
- Thorough knowledge of project management processes.
- Thorough knowledge of time and cost estimate development.
- Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
- Broad knowledge of drug development process and client needs.
Preferred:
- Masters or other advanced degree.
- PMP certification
- Detailed knowledge of Covance and the overall structure of the organization.
- Basic knowledge of Covance sales and business development strategies and procedures.
- Thorough knowledge of Covance SOPs
Experience - Minimum of nine (9) years relevant clinical research experience in a pharmaceutical company/CRO, including at least four (4) years of full project management responsibility.
- In lieu of the above requirement, candidates with > six (6) years supervisory experience in a health care setting and > seven (7) years clinical research experience including four (4) years of project management experience in the pharmaceutical or CRO industries will be considered.
- Experience in managing complex programs with significant financial value and complicated structure, multiple vendors and/or sub-CROs and Academic Research Organizations in a virtual environment.
- Demonstrated ability to handle multiple competing priorities.
- Ability to utilize resources effectively including programs with multiple budgets.
- Financial awareness and ability to actively manage financial tracking systems.
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
- Demonstrated ability to lead by example and to encourage team members to seek solutions.
- Excellent presentation skills and confidence presenting to senior management.
- Excellent communication, planning and organizational skills.
- Ability to work independently.
- Ability to negotiate and liaise with clients in a professional manner.
- Ability to present to staff at all levels.
- Ability to mentor junior level staff.
- Good computer skills with good working knowledge of range of computer programs.
Indianapolis, IN
Indianapolis, Indiana
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